ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 15¿
Check against the official notice below — it lists the full affected range.
Globus Medical is recalling specific lots of ALTERA Spacer implants (10x36, 9-13mm, 15°) because internal components in certain units may have been manufactured from stainless steel instead of the specified cobalt chromium molybdenum alloy. The affected lots have part number 1124.1232 and include six specific lot numbers: BAX103UE, BAX138JE, BAX167VE, BAX167UE, BAX227JE, and BAX413ME. The implants were distributed worldwide.
The recall notice does not specify a remedy or course of action for consumers who may have received affected implants.
Written by software from the official notice below. Not reviewed by a lawyer.
Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
Reason for recall: Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. Distribution: Worldwide Distribution Quantity: N/A Lot/code info: Part #: 1124.1232; Lot # / UDI #: BAX103UE / (01)00889095069945(10)BAX103UE; BAX138JE / (01)00889095069945(10)BAX138JE; BAX167VE / (01)00889095069945(10)BAX167VE; BAX167UE / (01)00889095069945(10)BAX167UE; BAX227JE / (01)00889095069945(10)BAX227JE; BAX413ME / (01)00889095069945(10)BAX413ME
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.